Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 484
- 试验地点
- 12
- 主要终点
- Change in Suicidal behavior as assessed by the Suicide Assessment Five-step Evaluation and Triage (SAFE-T) with Columbia-Suicide Severity Rating Scale (C-SSRS) Recent
研究概览
简要总结
The study will compare the effectiveness of two relatively brief and scalable evidence-based interventions: the Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+), a suicide-specific intervention that helps people prevent suicidal crises from escalating, and Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI), a psychotherapeutic crisis intervention treatment for suicidal adolescents that teaches youth skills to prevent suicidal crises and addresses interpersonal problems that lead to suicidal crises. The results will inform the future standard of care for youth at risk for suicide presenting in the ED setting. This project focuses on suicidal youth ages 12-24 in five ethnically and racially diverse urban areas: Philadelphia, Pennsylvania; Baltimore, Maryland; Chapel Hill, North Carolina; St. Petersburg, Florida; and Northern Manhattan/lower Bronx/eastern Queens communities in New York City, New York.
详细描述
Emergency department (ED) visits for suicide-related concerns have been increasing in youth over the past decade, a trend potentially exacerbated by the COVID-19 pandemic. Also, youth suicidal thoughts and attempts have increased with the 2019 Centers for Disease Control and Prevention (CDC) Youth Risk Behavior Surveillance System (YRBSS) finding that 18.8 percent of high school students have seriously considered suicide and 8.9 percent had attempted suicide in the past year. Furthermore, suicide rates are increasing more rapidly in Latino/Latina, Black, and multiracial youth, especially Black youth as compared to White youth. Similar increases in suicide risk are seen in lesbian, gay, bisexual, transgender, queer and other sexually minority (LGBTQ+) youth. This project focuses on suicidal youth ages 12-24 in five ethnically and racially diverse urban areas: Philadelphia, Pennsylvania; Baltimore, Maryland; Chapel Hill, North Carolina; St. Petersburg, Florida; and Northern Manhattan/lower Bronx/eastern Queens communities in New York City, New York.
There is limited evidence about which interventions are most helpful for suicidal youth in acute care settings such as EDs. Interventions like safety planning (Safety Planning Intervention with follow-up contacts) are delivered primarily in ED settings while others like Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) are provided primarily in outpatient settings. Furthermore, safety planning focuses on deescalating suicidal crises when beginning to occur, while IPT-A SCI focuses on developing skills to prevent crises from occurring. While both approaches have an evidence base, it is not yet known which one is more effective and acceptable in a diverse youth population. Determining which intervention is more effective has implications for dissemination and resource allocation to EDs or outpatient settings.
The research team includes a group of ethnically and racially diverse partners and advisors, advocates, researchers, ED physicians, nurses, and social workers, some of whom have lived experience of suicide attempts and suicide loss. This team has provided feedback about crucial elements of this proposal, e.g., recruitment, intervention approaches, and follow-up approaches and will continue active involvement in all stages of this project.
The study will compare the effectiveness of two relatively brief and scalable evidence-based interventions: the SPI+, a suicide-specific intervention that helps people prevent suicidal crises from escalating, and IPT-A SCI, a psychotherapeutic crisis intervention treatment for suicidal adolescents that teaches youth skills to prevent suicidal crises and addresses interpersonal problems that lead to suicidal crises. The results will inform the future standard of care for youth at risk for suicide presenting in the ED setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suicide Risk During Acute Care Visit (At least one item in risk assessment is required; check all that apply): ___ Chief complaint of suicide-related concern (via Medical Record/Other), ___ Active suicidal ideation endorsed in past 1 month on validated suicide screener, ___ Suicidal behavior in the past 3 months on validated suicide screener, ___ Clinician indicated SI in past month or SA in past 3 months.
- •Have access to a cellular phone with the ability to receive phone calls and text messages over the 12-month follow- up period
- •Adolescent must be verbally fluent and can communicate, understand, and read in either English or Spanish
- •Adolescent has been/will be discharged from a higher level of care (i.e. inpatient, day hospital, partial hospitalization program (PHP), or residential treatment program) and back in the community within 4 weeks of their acute care visit. [Note: this criterion does not apply to all patients - select N/A if this is the case.
排除标准
- •Significant cognitive or developmental delays that prevent understanding or using SPI+ or IPT-A-SCI (includes inability to communicate verbally)
- •Altered mental status (acute psychosis, intoxication, or mania)
- •Unable or unwilling to provide informed consent (adults), assent (minors), or permission (parents/caregivers)
- •The services offered through the study are not in the best clinical interest of the patient (e.g., presenting problem requires a different level of care or treatment approach).
研究组 & 干预措施
Safety Planning Intervention
The SPI is a brief, evidence- based intervention that provides people with an individualized set of steps that can be used progressively to both reduce risk and maintain safety when suicide ideation (SI) emerges. Safety plans are developed collaboratively between providers, at risk youth, and family members when possible. Core SPI components include recognizing warning signs of an imminent suicidal crisis (e.g., changes in mood, thoughts or behaviors); using internal coping skills to reduce distress; using people or places in the individual's support network as a means of distraction from SI; reaching out to family or friends to help manage the crisis; contacting health professionals or emergency services; and reducing access to lethal means. SPI+ includes a brief follow-up component post- discharge that includes contacting the patient for a mood and risk check-in; reviewing and revising the safety plan; and facilitating connection with community mental health services.
干预措施: Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+) (Behavioral)
Ultra-Brief Crisis IPT-A
Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) is a scalable, flexible, and extensively examined mental health treatment developed to reduce depressive symptoms and improve interpersonal functioning, and has been adapted for use in adolescents (IPT-A SCI) and shown to be effective in treating depression and reducing associated suicide risk. Interpersonal problems are often at the core of suicidal thinking and behavior in youths including minority youths.
干预措施: Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) (Behavioral)
结局指标
主要结局
Change in Suicidal behavior as assessed by the Suicide Assessment Five-step Evaluation and Triage (SAFE-T) with Columbia-Suicide Severity Rating Scale (C-SSRS) Recent
时间窗: baseline, 3 months, 6 months, 12 months
Suicidal behavior with intent to die: measured using the Suicide Assessment Five-step Evaluation and Triage (SAFE-T) with Columbia-Suicide Severity Rating Scale (C-SSRS) Recent. Scored 0 to 1, with 1 indicating a suicide attempt since last assessment.
Change in Suicidal ideation as assessed by the Suicide Assessment Five-step Evaluation and Triage (SAFE-T) with Columbia-Suicide Severity Rating Scale (C-SSRS) Recent
时间窗: baseline, 3 months, 6 months, 12 months
Suicidal thoughts: measured using the Suicide Assessment Five-step Evaluation and Triage (SAFE-T) with Columbia-Suicide Severity Rating Scale (C-SSRS) Recent. Scores for suicidal ideation range from 0 to 5, with higher scores indicating more serious suicidal ideation, where 0 = "no suicidal thoughts"; 1= "wish to be dead"; 2 = "nonspecific active suicidal thoughts"; 3 = "suicidal thoughts with methods"; 4 = "suicidal intent"; and 5 = "suicidal intent with plan".
Number of Suicides
时间窗: 12 months
Measured through Death Records or Suicide from Office of Chief Medical Examiner, family report or medical record
次要结局
- Change in social interactions with peers as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Peer Relationships scale.(baseline, 3 months, 6 months, 12 months)
- Change in Generalized Anxiety Disorder as assessed by the The Generalized Anxiety Disorder 7 question scale (GAD-7).(baseline, 3 months, 6 months, 12 months)
- Change in social interactions with family as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Family Relationships scale.(baseline, 3 months, 6 months, 12 months)
- Change in Frequency of mental health service utilization as assessed by Services Assessment for Children and Adolescents (SACA)(baseline, 3 months, 6 months, 12 months)
- Change in Self reported Quality of Life as assessed by the Euro-Qol 5-Dimension 3-level tool (EQ-5D-3L)(baseline, 3 months, 6 months, 12 months)
- Change in Self reported Quality of Life as assessed by the Euro-Qol 5-Dimension Youth (EQ-5D-Y)(baseline, 3 months, 6 months, 12 months)
- Change in Depression severity as assessed by the nine-item Patient Health Questionnaire (PHQ-9).(baseline, 3 months, 6 months, 12 months)
- Change in conflicts with family members as assessed by the Conflict Behavior Questionnaire (CBQ).(baseline, 3 months, 6 months, 12 months)
- Change in skill use derived from the Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+) arm(3 months, 6 months, 12 months)
- Change in skill use derived from the Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI) arm(3 months, 6 months, 12 months)